Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

Starting soon · Phase 3

Conditions studied: Acute Ischemic Stroke, Large Vessel Occlusion, Anterior Circulation Brain Infarction

In brief

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain. The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT. Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

Key facts

Study ID

NCT07748039

Run by

Yongjun Wang

People needed

1440

Starts

2026-08-01

Expected to finish

2029-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening.
• Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1
• Age ⩾ 18 years at the time of signing the informed consent form
• ASPECTS 6-10
• Informed consent from the patients or their legal representative.

You may not qualify if…

• Intracranial hemorrhage (ICH) identified by CT or MRI
• Rapidly improving symptoms at the discretion of the investigator
• mRS > 2 before stroke onset.
• Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT.
• Known contraindication to imaging with contrast agents
• Planned adjunct intra-arterial (IA) thrombolysis during or after endovascular treatment (EVT).
• Secondary transfer from a primary stroke center
• Any terminal illness such that patient would not be expected to survive more than one year
• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
• Pregnant women

Where it is running

• Beijing Tiantan Hospital, Capital Medical Universiity — Beijing, Beijing Municipality, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• Xiangtan Central Hospital — Xiangtan, Hunan, China
• Rizhao Hospital of Traditional Chinese Medicine — Rizhao, Shandong, China
• Ya'an People's Hospital — Ya'an, Sichuan, China

Full record on ClinicalTrials.gov

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